A Prospective Cohort Study on the Effect of Spinal Spinal Cord Injury on Sexual Function in Male Patients

Active, not recruiting

• Conditions: Sexual Function Abnormal; Spinal Cord Injuries (SCI)
• Interventions: Procedure: Posterior decompression surgery; Procedure: unilateral open-door laminoplasty; Procedure: Posterior lumbar discectomy with fusion; Procedure: Surgical resection of spinal tumors; Drug: Conservative management of ankylosing spondylitis; Procedure: anterior cervical discectomy/fusion; Drug: Conservative management of lumbar spinal stenosis; Procedure: decompression surgery for caudal plexus disorder; Procedure: anterior cervical corpectomy/fusion

• Registration Number: NCT07093827
• Lead Sponsor: Peking University Third Hospital

Brief Summary

1. Background and Rationale

Spinal cord injury (SCI) represents a devastating neurological condition with multidimensional consequences. While motor and sensory deficits are well-characterized, sexual dysfunction remains understudied despite its profound impact on quality of life. Current literature exhibits three critical gaps: (1) Limited longitudinal data on the temporal evolution of sexual dysfunction post-SCI, (2) Inadequate differentiation between psychogenic vs. neurogenic mechanisms in male patients, and (3) Heterogeneous outcome measures hindering cross-study comparisons。 This investigation builds upon pilot findings from our institution's SCI registry, where a large proportion of male participants reported clinically significant sexual impairment within 24 months post-injury. By employing standardized neuro-urological assessments alongside validated psychometric tools, this study aims to dissect the complex interplay between neurological lesion characteristics, endocrine profiles, and psychosocial adaptation processes.

2. Study Objectives

Primary Objective To quantify the prevalence and severity trajectories of sexual dysfunction in males with SCI post-injury.

Secondary Objectives To correlate lesion level with specific sexual function domains To identify predictors of sexual health recovery using multivariate regression modeling To establish normative data for the sexual function in SCI populations

3. Methodology

3.1 Study Design

Prospective observational cohort with three nested substudies:

Substudy A: Longitudinal biomechanical assessments Substudy B: Endocrine profiling Substudy C: Qualitative interviews exploring coping mechanisms

3.2 Participant Selection

Inclusion Criteria:

Males aged 18-60 years SCI confirmed by raiological methods or clinical symptoms Willing to participate in long-term follow-up

Exclusion Criteria:

Pre-existing sexual dysfunction History of prior surgical procedures Active psychiatric comorbidities 3.3 Data Collection Timeline Timepoint Assessments Baseline Neurological function, sexual function, raiological outcome 3-month Neurological function, sexual function, raiological outcome 12-month Neurological function, sexual function, raiological outcome 24-month Neurological function, sexual function, raiological outcome 36-month Neurological function, sexual function, raiological outcome 48-month Neurological function, sexual function, raiological outcome 60-month Neurological function, sexual function, raiological outcome

Detailed Description

Spinal cord injury (SCI) induces complex pathophysiological alterations extending beyond motor-sensory impairments, with sexual dysfunction emerging as a clinically significant yet insufficiently characterized sequela. This investigation specifically targets three critical knowledge gaps in SCI-related sexual dysfunction: First, regarding neurogenic versus psychogenic differentiation, supraspinal lesions manifest through autonomic dysreflexia-mediated hemodynamic alterations in genital perfusion, while psychological comorbidities predominantly modulate libido and arousal domains. Second, concerning temporal progression dynamics, our institutional pilot data demonstrated 68% of male SCI patients developed clinically significant sexual impairment within 24 months post-injury, though precise trajectory patterns remain uncharacterized. Third, from a biomarker integration perspective, this study will employ cortisol/DHEA-S ratio analysis combined with nocturnal penile tumescence (NPT) monitoring to objectively delineate the endocrine-neurological crosstalk underlying post-SCI sexual dysfunction pathophysiology.

This study employs a robust methodological framework comprising a primary prospective observational cohort (N=180), stratified by both anatomical lesion level and neurological impairment severity. The research architecture incorporates three integrated substudies utilizing advanced multimodal assessment protocols: Substudy A applies penile duplex ultrasonography (PDU), coupled with Rigiscan® technology, International Index of Erectile Function-5 (IIEF-5) and the Premature Ejaculation Diagnostic Tool (PEDT) to quantitatively evaluate sexual parameters; Substudy B conducts high-sensitivity LC-MS/MS serum assays (testosterone, prolactin, SHBG) to systematically characterize hypothalamic-pituitary-adrenal axis dysregulation patterns post-SCI; while Substudy C employs grounded theory methodology to analyze semi-structured interviews, establishing an evidence-based model of psychosocial coping strategy efficacy validated through the International Spinal Cord Injury Male Sexual Function (ISCI-MSF) Basic Data Set and the ICIQ-ADPHS instrument. This tripartite approach ensures comprehensive mechanistic investigation across biomechanical, endocrine, and psychosocial dimensions of post-SCI sexual dysfunction.

The study implements a comprehensive data acquisition protocol employing validated quantitative metrics across multiple domains. Longitudinal data collection occurs at predetermined intervals throughout the 60-month study period. For analytical rigor, we employ group-based trajectory modeling (GBTM) to characterize IIEF score evolution, LASSO-penalized Cox regression for time-to-recovery analysis, and partial least squares path modeling (PLS-PM) to examine mechanistic relationships between lesion level and autonomic function, endocrine profiles and arousal metrics, and depression (PHQ-9) and desire domains. Normative data development utilizes kernel density estimation to establish age-stratified IIEF reference curves, while minimum detectable change (MDC) is determined through anchor-based methods incorporating the PGIC scale, ensuring clinically meaningful interpretation of results.

This investigation incorporates several cutting-edge technical innovations to enhance methodological rigor and analytical precision: standardized biobanking procedures maintain serum aliquots to facilitate future omics-based investigations; and advanced convolutional neural networks (CNNs) automate penile duplex ultrasonography (PDU) waveform analysis to ensure objective, reproducible measurements. To maintain the highest standards of data quality, we implement robust quality assurance protocols including centralized blinding procedures for IIEF scoring (inter-rater reliability κ\>0.85), multiple imputation by chained equations (MICE) to address missing data, and quarterly phantom testing of Rigiscan® equipment to verify measurement accuracy (maintaining \<5% error tolerance). These integrated technological and methodological safeguards ensure the collection of high-fidelity data while enabling novel multidimensional analyses of post-SCI sexual dysfunction pathophysiology.

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-30
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30
• Primary Completion: 2030-01-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 1600

Inclusion Criteria

1. Biological males aged 18-60 years
2. Married or sexually active prior to injury
3. Diagnosed with pre-specified diseases
4. American Spinal Injury Association (ASIA) Impairment Scale grade B-D at admission

Exclusion Criteria

1. Post-traumatic respiratory failure requiring mechanical ventilation
2. History of prior spinal procedures or traumatic cord injuries
3. Incomplete clinical/radiological documentation
4. Insufficient follow-up duration (<24 months post-intervention)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
thoracolumber fracture	Posterior decompression surgery	-
Cervical spinal cord injury without fracture or dislocation	unilateral open-door laminoplasty	-
Lumbar disc herniation	Posterior lumbar discectomy with fusion	-
Spine tumors	Surgical resection of spinal tumors	-
Ankylosing spondylitis	Conservative management of ankylosing spondylitis	-
Ankylosing spondylitis	decompression surgery for caudal plexus disorder	-
Cervical spondylosis of the spinal cord	anterior cervical discectomy/fusion	-
Cervical spondylosis of the spinal cord	anterior cervical corpectomy/fusion	-
Lumbar stenosis	Conservative management of lumbar spinal stenosis	-

Primary Outcome Measures

Name	Time	Method
the Premature Ejaculation Diagnostic Tool (PEDT)	baseline (before injury), immediately after injury, 1, 3, 6, 12, 24, 36, 60 months after surgery	Premature ejaculation status was determined using the PEDT, classified as confirmed (≥11, Grade 1), borderline (9-10, Grade 2), or absent (≤8, Grade 3), with lower scores reflecting improved ejaculatory control.
International Index of Erectile Function-5 (IIEF-5)	baseline (before injury), immediately after injury, 1, 3, 6, 12, 24, 36, 60 months after surgery	Erectile function was quantitatively assessed via the IIEF-5, categorized into ordinal grades: severe dysfunction (1-7, Grade 1), moderate (8-11, Grade 2), mild (12-21, Grade 3), and normal (22-25, Grade 4), where higher scores denoted preserved erectile capacity.
American Spinal Injury Association (ASIA) Impairment Scale	baseline (before injury), immediately after injury, 1, 3, 6, 12, 24, 36, 60 months after surgery	Neurological and functional outcomes were prospectively assessed through standardized outpatient evaluations and telemedicine follow-ups. Sensory and motor functions were classified using the ASIA Impairment Scale, the internationally recognized benchmark for spinal cord injury severity.

Secondary Outcome Measures

Name	Time	Method
preoperative high cord signals (HCS) in MRI T2WIs	immediately after injury, 1, 12, 24, 36, 60 months after surgery	Intramedullary hyperintensity was quantified using mid-sagittal T2-weighted MRI: circular regions of interest (ROIs, 0.05 cm²) were delineated at sites of maximal cord hyperintensity, with reference ROIs (0.3 cm²) sampled at C7-T1 (Figure 2). The SIR was calculated as mean pathological ROI intensity divided by mean reference ROI intensity; SIR ≥1.32 defined HCS, indicative of edema, hemorrhage or liquefaction.
the rate of spinal cord compression	immediately after injury	Spinal cord compression rate was computed from axial T2-MRI measurements as \[(uncompressed anteroposterior spinal cord diameter - maximal compressed diameter)/uncompressed diameter\] × 100% (Figure 3), with ≥20% denoting significant compression.
the International Spinal Cord Injury Male Sexual Function (ISCI-MSF) Basic Data Set	immediately after injury, 1, 3, 6, 12, 24, 36, 60 months after surgery	The ISCI-MSF Basic Data Set prospectively captured psychosexual parameters, including sexual communication willingness, reflexogenic/psychogenic erection capacity, and orgasmic function.
Torg-Pavlov ratio	immediately after injury, 1, 12, 24, 36, 60 months after surgery	The TPR-a validated radiographic marker for developmental spinal canal stenosis-was derived by dividing mid-sagittal spinal canal diameter by corresponding vertebral body diameter on neutral lateral radiographs, measured via calibrated digital calipers.
number of levels fused	immediately after surgery

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China